MAV · Class II · 21 CFR 870.1650

FDA Product Code MAV: Syringe, Balloon Inflation

Leading manufacturers include Medtronic Vascular.

57
Total
57
Cleared
120d
Avg days
1981
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Syringe, Balloon Inflation Devices (Product Code MAV)

57 devices
1–24 of 57

About Product Code MAV - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code MAV since 1981, with 57 receiving FDA clearance (average review time: 120 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

MAV devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →